FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Gastroenterology & Urology ×
9,870 results
4945–4968 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Sep 25, 1997
GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET
K955497 · KDL
Cobe Renal Care, Inc.
Gastroenterology & Urology · 664d
Cleared Sep 23, 1997
ANORECTAL MANOMETRY ANALYSIS MODULE
K972439 · FFX
Medtronic-Synectics
Gastroenterology & Urology · 85d
Cleared Sep 19, 1997
GR100F URINE FLOWMETER
K971913 · EXY
Albyn Medical , Ltd.
Gastroenterology & Urology · 120d
Cleared Sep 19, 1997
IN-SLING
K972651 · OTN
Influence, Inc.
Gastroenterology & Urology · 67d
Cleared Sep 19, 1997
OT-1
K972781 · FED
Prism Therapeutics, LLC
Gastroenterology & Urology · 56d
Cleared Sep 19, 1997
SILICONE BILIARY STENT/BILIARY CATHETER
K973114 · FGE
Specialty Surgical Products, Inc.
Gastroenterology & Urology · 30d
Cleared Sep 18, 1997
SEAGER ELECTROEJACULATOR
K962379 · LNL
National Rehab Hospital
Gastroenterology & Urology · 455d
Cleared Sep 18, 1997
RESUABLE HOT BIOPSY FORCEPS
K972505 · KGE
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 77d
Cleared Sep 18, 1997
S-357 VIDEO IMAGING SYSTEM
K972540 · FET
Sopro
Gastroenterology & Urology · 73d
Cleared Sep 15, 1997
AUXILIARY INSTRUMENTS FOR URS
K971315 · FCL
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 159d
Cleared Sep 10, 1997
K&W 2-PIECE TAKE-APART INSTRUMENTS(VARIOUS)
K973259 · OCZ
Medical Creative Technologies, Inc.
Gastroenterology & Urology · 12d
Cleared Sep 09, 1997
BLOOD MONITOR PUMP
K970591 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 203d
Cleared Sep 09, 1997
JIMMY JOHN III RECTAL NOZZEL, MODEL CIT
K972455 · KPL
Colon Therapeutics
Gastroenterology & Urology · 70d
Cleared Sep 08, 1997
5 STAR MEDICAL ENDOSCOPE
K963354 · ODF
Five Star Medical, Inc.
Gastroenterology & Urology · 378d
Cleared Sep 05, 1997
FLEX-NECK PD CATHETER
K970159 · FJS
Janin Group, Inc.
Gastroenterology & Urology · 232d
Cleared Aug 29, 1997
AMS FOREIGN BODY EXTRATOR
K972091 · FFL
American Medical Systems, Inc.
Gastroenterology & Urology · 86d
Cleared Aug 29, 1997
URESIL GENERAL PURPOSE DRAINAGE CATHETER, URESIL NEPHROSTOMY CATHETER, URESIL...
K972583 · FGE
Uresil Corp.
Gastroenterology & Urology · 50d
Cleared Aug 28, 1997
FEMALE EXTERNAL URINARY COLLECTION POUCH
K971499 · EXI
Mediquest, Inc.
Gastroenterology & Urology · 125d
Cleared Aug 20, 1997
JEJENOSTOMY FEEDING TUBE
K971906 · FPD
Boston Scientific Corp
Gastroenterology & Urology · 89d
Cleared Aug 19, 1997
NIAGARA DUAL LUMEN CATHETER
K965178 · MPB
Vas-Cath, Inc.
Gastroenterology & Urology · 238d
Cleared Aug 18, 1997
BESECURE EXTERNAL URINARY COLLECTION SYSTEM
K971271 · KNX
Urology Research Intl., Inc.
Gastroenterology & Urology · 136d
Cleared Aug 18, 1997
POTTY PAL AND FOREVER-DRY
K971855 · KPN
Digital Applications, Inc.
Gastroenterology & Urology · 90d
Cleared Aug 18, 1997
MEDISYSTEMS DIALYSIS PRIMING SETS
K971860 · KOC
Medisystems Corp.
Gastroenterology & Urology · 90d
Cleared Aug 15, 1997
MEDISYSTEMS PERITONEAL DIALYSIS SETS
K963668 · KDJ
Medisystems Corp.
Gastroenterology & Urology · 336d